The $4,000 Diet Pill

It sounds like something out of Alice in Wonderland: a pill that truly makes you smaller. "Pill," however, is something of a misnomer because inside this capsule is actually a deflated balloon, called the Obalon. But it can help you shed pounds—without even trying. Here's how it works: First, you swallow the pill, which is attached to a long, slim tube. Once the pill has made its way to your stomach, doctors use the tube to inflate the balloon with gas; the tube is then disconnected and pulled out. The balloon can stay in for up to three months, and you can have up to three balloons in place at a time. The idea is that the balloon(s) simply make you feel full. After 12 weeks, during an endoscopy done under light sedation, a doctor deflates the balloon and removes it through your mouth.

Although manufacturer Obalon Therapeutics makes no specific weight loss promise, in a recent study, 110 patients lost an average of 50 percent of their excess weight, or more than 8 percent of their total body weight, in three months. And while the Obalon is not FDA approved for use in the U.S., since 2012, patients abroad have been swallowing the pill, which has a price tag of up to $4,000 a pop. (In the U.S., preliminary safety trials have been done, and a larger, clinical trial is planned.) The most common complaints are nausea and vomiting, but those tend to dissipate after 72 hours, says bariatric surgeon Ariel Ortiz, director of the Obesity Control Center in Tijuana, Mexico, who helped develop the Obalon. As with any device, there's a chance it could cause an obstruction if it got lodged in a tight spot, notes bariatric surgeon Aurora Pryor, director of Stony Brook Medicine's Bariatric and Metabolic Weight Loss Center on New York's Long Island. The odds of a balloon actually popping are rare, according to Obalon, but if that were to occur, it should travel (uneventfully) through to your, um, bottom line.

For U.K. resident Helene Fleckney, 45, the Obalon has ended a long struggle with her weight. Fleckney enrolled in an Obalon trial last fall, ultimately swallowing two of the pills over several weeks. Twelve weeks later she had both balloons removed—and was 19 pounds lighter. "It's quick and painless," says Fleckney, who notes that she has lost an additional six pounds since then. "I've gotten used to eating smaller portions," she says. This pill "could be a serious game changer in the field of obesity treatment," says John Morton, director of bariatric surgery at Stanford Hospital & Clinics in Palo Alto, California. Pryor says that a reversible device like this could straddle the line between bariatric and plastic surgery: "I could imagine someone wanting this before a big reunion or something." And for some people, doing it a few times in a row may mean they can extend the treatment past the three-month mark, although studies of that duration have not been done.

Of course, the Obalon isn't the only gastric device out there. GI Dynamics' EndoBarrier is a thin plastic sleeve that's inserted through the mouth into the uppermost portion of the small intestine. With the sleeve anchored in place for up to a year, food passes through but calories aren't absorbed until it's farther down the GI tract, which increases the metabolic rate, says internist Louis J. Aronne, director of the Center for Weight Management and Metabolic Clinical Research at New York's Weill Cornell Medical College, who is helping to oversee the U.S. clinical trial. But perhaps more important, the device alters the release of hormones in the gut, including insulin, in ways that help reduce appetite and regulate blood sugar levels. EndoBarrier has been used overseas since 2010 for the treatment of obesity and type II diabetes, conditions that often go hand in hand. (The company makes no specific weight loss claim, but in a recent study, patients lost an average of almost 20 percent of their body weight in 12 months.) Current cost abroad: $8,500–$13,000. "Honestly, we don't entirely understand how it all works," says Lee Michael Kaplan, a gastroenterologist at Massachusetts General Hospital and the principal investigator overseeing the U.S. trial. "But we do know that within weeks of having this device inserted, people report increased satiety, probably due to a greater release of hormones that make you feel full," Kaplan says.

EndoBarrier helped Tania Hale, 37, of Britain, lose almost 30 pounds in six months. For Hale, the procedure was easy, and the only side effect has been a transient tummy-ache. Other possible but unlikely hazards are bleeding, infection, and migration of the device. "I think it's wonderful," says Hale. Yet, like Fleckney, Hale acknowledges that while EndoBarrier did its job, she still has to do hers—remaining committed to diet and lifestyle changes. Because though you may be able to fork over $4K—or more—for a device that promises a leg up on weight loss, keeping it off is truly priceless.

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